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Title:  Senior Executive

Date:  Jul 11, 2024
Location:  Tandalja - R&D
Company:  Sun Pharmaceutical Industries Ltd

SR. NO.

MAJOR RESPONSIBILITY / ACCOUNTABILITIES

1

He/she would assume to support literature/patent search & prepare summary report.

2

Responsible for all regulatory documents drafting like CC,PDR,PD, Pre-IND /IND / NDA Package ,IND & documents for DCGI submission

3

Resource Management - procure raw material (API/Excipients), packing material & innovator samples in consultation with packing/Purchase department.

4

Responsible for conduct pre-formulation and prototype experiments.

5

Red Flagging of issues at the right time. Highlighting Key Issues to reporting managers which impacts the Program timelines/deliverables

6

Understanding to establish product development strategy

7

Responsible for tech-transfer and regulatory filing documents

8

Responsible to stability studies, analytical method development & validation

9

He/she would be responsible for process scalability at plant and subsequent Exhibit / Clinical batches

10

Responsible for prepare risk assessment report for elemental impurity, nitrosamine impurity and E&L

11

Assist in trouble shooting and provide suggestions for corrective and preventive actions

12

Prepare SOPs for laboratory equipment/instrument.

13

Be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare/ review qualification documents.

14

Other accountabilities as applicable as per needs of dynamic business environment

 

Required Skills

 

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